The TARGET BP OFF-MED Trial

Phase 2

Completed

• Conditions: Hypertension,Essential; Hypertension
• Interventions: Other: Sham control; Drug: Alcohol

• Registration Number: NCT03503773
• Lead Sponsor: Ablative Solutions, Inc.

Brief Summary

To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in hypertensive subjects in the absence of antihypertensive medications.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-20
• Study Start: 2018-09-24
• Primary Completion: 2022-01-31
• Results First Submitted: 2023-11-10
• Study Completion: 2024-01-10
• Results First Submitted QC: 2024-06-20
• Results First Posted: 2024-10-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Has 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥140 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg.
2. Subject is willing to discontinue any current antihypertensive medications during the run-in period and the post-treatment period.
3. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings

Exclusion Criteria

1. Subject has renal artery anatomy abnormalities.
2. Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy.
3. Subject has documented sleep apnea.
4. Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association [NYHA] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic pressure).
5. Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
6. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed.
7. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Control Arm	Sham control	Only renal angiography performed
Treatment Arm:	Alcohol	Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter

Primary Outcome Measures

Name	Time	Method
Changes in Systolic Ambulatory Blood Pressure	Baseline to 8 weeks post-treatment	Change from baseline in mean 24-hour ambulatory systolic blood pressure

Secondary Outcome Measures

Name	Time	Method
Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months	6 months	Change from baseline in mean 24-hour ambulatory systolic blood pressure from baseline to 6 months
Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months	12 months	Change from baseline in mean 24-hour systolic blood pressure at 12 months post-procedure
Change in Office SBP at 8 Weeks	8 weeks	Change from Baseline in mean office SBP to Week 8
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks	8 weeks	Change from baseline in mean 24-hour ambulatory diastolic blood pressure and 8 weeks post-procedure
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months	6 months	Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 6 months post-procedure
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months	12 months	Change from baseline in mean 24-hour diastolic blood pressure 12 months post-procedure
Number of Participants With Major Adverse Events (MAEs)	30 days post procedure	Number of participants with major adverse events (MAEs) 30 days post-procedure
Use of Antihypertensive Medication(s)	8 weeks	Use of antihypertensive medication at 8 weeks
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks	8 weeks	Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 8 Weeks
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months	6 months	Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 6 Months
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months	12 months	Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 12 Months
Mean Daytime Ambulatory Diastolic Blood Pressure	8 weeks	Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 8 Weeks
Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months	6 months	Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 6 months
Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months	12 months	Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 12 Months
Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks	8 weeks	Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 8 Weeks
Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months	6 months	Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 6 Months
Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months	12 months	Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks	8 weeks	Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 8 weeks
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months	6 months	Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 6 Months
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months	12 months	Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 12 Months
Change in Mean Office SBP at 6 Months	6 months	Change from Baseline in mean office SBP to 6 Months
Change in Mean Office SBP to 12 Months	12 months	Change from Baseline in mean office SBP to 12 Months
Change in Mean Office DBP to 8 Weeks	8 weeks	Change from Baseline in mean office DBP to 8 Weeks
Change in Mean Office DBP to 6 Months	6 months	Change from Baseline in mean office DBP to 6 Months
Change in Mean Office DBP at 12 Months	12 months	Change from Baseline in mean office DBP to 12 Months

Trial Locations

Locations (4)

NIHR Barts Cardiovascular Biomedical Research Unit; 🇬🇧 London, United Kingdom

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg/Saar, Germany

Clinique Pasteur Toulouse; 🇫🇷 Toulouse, France

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium